(170 days)
No
The document describes a medical display monitor and associated quality control software. There is no mention of AI or ML capabilities in the device description, intended use, or performance studies. The focus is on display performance and conformance to standards like DICOM GSDF.
No
The device is a medical image display monitor used for diagnosis, not for directly treating or preventing a disease or condition.
No
The device is a medical monitor designed for displaying medical images for diagnosis, but it does not perform the diagnosis itself. The diagnostic process is carried out by trained medical practitioners viewing the images on the monitor.
No
The primary device described is a color LCD monitor (RadiForce MX270W), which is a hardware component. While it includes accessory software (RadiCS), the core device is not software-only.
Based on the provided information, the RadiForce MX270W is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states it's for "displaying and viewing digital images for diagnosis of X-ray or MRI, etc." This is related to medical imaging, not the analysis of biological samples outside the body, which is the core of IVD.
- Device Description: The description focuses on the technical specifications of a monitor designed for displaying medical images. It mentions features like resolution, pixel pitch, tone curves (including DICOM GSDF), luminance, and color temperature, all relevant to image display quality.
- No Mention of Biological Samples or Assays: There is no mention of analyzing blood, urine, tissue, or any other biological sample, nor is there any description of assays or tests performed on such samples.
- Focus on Image Display and Quality Control: The performance studies and the mention of RadiCS software are all related to the quality and accuracy of the image display, which is crucial for diagnostic imaging but not indicative of an IVD.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The RadiForce MX270W's function is to present images generated by other medical devices (like X-ray or MRI machines) to a medical practitioner for interpretation. It does not perform any analysis on biological samples itself.
N/A
Intended Use / Indications for Use
The RadiForce MX270W is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device is not for use for screening or diagnostic mammography.
Product codes
LLZ
Device Description
The RadiForce MX270W is a color LCD monitor for viewing medical images other than those of mammography. The matrix size (or resolution) of the panel is 2560 x 1440 pixels (3.7MP) with a pixel pitch of 0.233 mm.
Since factory calibrated display modes, each of which is characterized by a specific tone curve (including DICOM GSDF), a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor, the tone curve is e.g. DICOM compliant regardless of the display controller used.
RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including MX270W based on several QC guidelines. The RadiCS and its subset, RadiCS LE are included in this 510(k) submission as an accessory to the RadiForce MX270W.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray or MRI
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical practitioners
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The following bench tests were performed on the RadiForce MX270W :
- Verification of the conformance to DICOM GSDF as specified in Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 guideline)
- Measurement of the luminance non-uniformity characteristics of the display screen as specified in the TG18 guideline
- Measurement of the chromaticity non-uniformity characteristics of the display screen as specified in the TG18 guideline
- Measurement of the chromaticity at the center of the display screen at 5%, 50% and 95% of the maximum luminance as specified in Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions
- Visual check of presence or absence of miscellaneous artifacts on the display screen as specified in the TG18 guideline
- The maximum number allowed for each type of pixel defects/faults agreed with the manufacturer from which Eizo buys the LCD panels for RadiForce MX270W
The test results showed that the RadiForce MX270W has display performances substantially equivalence to those of the predicate device, RadiForce RS210. Besides, the display performances of the RadiForce MX270W meet the pre-defined criteria when criteria are set.
No animal or clinical testing was performed on the RadiForce MX270W.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/0 description: The image shows the logo for EIZO. The logo consists of a stylized, geometric shape above the company name. The shape is composed of a combination of solid black areas and a checkered pattern, giving it a three-dimensional appearance. The company name "EIZO" is printed in a bold, sans-serif font below the shape.
APR 2 0 2012
| EIZO NANAO CORPORATION, 153 Shimokashiwano, Hakusan, Ishikawa
| 924-8566 Japan | Name | Hiroaki Hashimoto |
|---|---|---|
| U.S. Food and Drug Administration | Department | Medical Device Standard |
| Center for Devices and Radiological Health | ||
| Document Mail Center - WO66-G609 | Telephone | +81 (76) 274-2468 |
| 10903 New Hampshire Avenue | Fax | +81 (76) 274-2484 |
| Silver Spring, MD 20993-0002 | hiro@nanao.co.jp | |
| Date | October 25th, 2011 |
Traditional 510(k) Summary (in accordance with 21 CFR 807,92)
-
- Date of Summary
October 25th, 2011
- Date of Summary
-
- Company EIZO NANAO CORPORATION 153 Shimokashiwano, Hakusan Ishikawa 924-8566 Japan
-
- Authorized Contact Person Hiroaki Hashimoto
4. Device Information
- . Trade Name/Model: RadiForce MX270W
- . Common Name: 3.7MP Color LCD Monitor
- Classification Name: . System, Image Processing, Radiological
- Regulation Number: . 21 CFR 892.2050, Product Code LLZ
5. Predicate Device
- Color LCD Monitor, RadiForce RS210 (K092613) .
6. Device Description
The RadiForce MX270W is a color LCD monitor for viewing medical images other than those of mammography. The matrix size (or resolution) of the panel is 2560 x 1440 pixels (3.7MP) with a pixel pitch of 0.233 mm.
Since factory calibrated display modes, each of which is characterized by a specific tone curve (including DICOM GSDF), a specific luminance range and a specific color temperature, are stored in lookup tables within the monitor, the tone curve is e.g. DICOM compliant regardless of the display controller used.
1
RadiCS is application software to be installed in each workstation offering worry-free quality control of the diagnostic monitors including MX270W based on several QC guidelines. The RadiCS and its subset, RadiCS LE are included in this 510(k) submission as an accessory to the RadiForce MX270W.
7. Intended Use
The RadiForce MX270W is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device does not support the display of mammography images for diagnosis.
8. Technological Characteristics
The RadiForce MX270W can be said to have at least the same display performances as those of the predicate device by default due to the following reasons:
- Both the matrix size and the active area size of the LCD panel used (2,560 x 1,440, a. 596.7 mm x 335.6 mm) are larger than those of the predicate device (1,600 x 1,200, 432.0 mm x 324.0 mm).
- The smaller pixel pitch or pixel size (0.233 x 0.233 mm) than that of the predicate b. device (0.270 x 0.270 mm) means higher density usually resulting in higher quality of displayed images. If one cares about the smaller pixel size, the perceived pixel size similar to that of the predicate device can be realized easily by adjusting the viewing distance.
- The DICOM calibrated luminance (170 cd/m2) is higher than that of the predicate C. device (150 cd/m2) though the typical maximum luminance values of the both devices are the same (300 cd/m2). The higher calibrated luminance to be maintained constantly was realized by the employment of LED backlight deteriorating more slowly than conventional CCFL backlights.
- The LED backlight was newly employed instead of CCFL backlight because it is d. mercury-free, consumes less power and deteriorates more slowly. We have not recognized any adverse effects of the LED backlight on the quality of displayed images. Refer to section 18 "Performance Testing - Bench" where several image quality characteristics of the proposed device are compared with those of the predicate device.
- The both devices display images in accordance with DICOM GSDF by default e. utilizing the factory calibrated display mode stored in lookup tables inside of them.
- Analog video interface is not supported by the proposed device. The quality of f. displayed images is usually better via digital interfaces like DVI or DisplayPort than via analog ones.
As for the maintenance, the same QC software is used for the both devices and the implementation of the Backlight Sensor (BS) stabilizing the backlight is also the same.
2
As for built-in sensors, in addition to BS common to the both devices, MX270W has a Built-in Front Sensor (IFS). The IFS enables automatic grayscale calibration by measuring the luminance at the screen surface. Without IFS, the grayscale calibration process requires human intervention and the use of an external sensor. The accuracy data of the calibration with external sensors and that with the IFS is included in section 16.9 "Verification and Validation Documentation".
9. Performance Testing
The following bench tests were performed on the RadiForce MX270W :
- . Verification of the conformance to DICOM GSDF as specified in Assessment of Display Performance for Medical Imaging Systems by AAPM Task Group 18 (TG18 guideline)
- . Measurement of the luminance non-uniformity characteristics of the display screen as specified in the TG18 guideline
- Measurement of the chromaticity non-uniformity characteristics of the display screen as . specified in the TG18 guideline
- . Measurement of the chromaticity at the center of the display screen at 5%, 50% and 95% of the maximum luminance as specified in Guidance for Industry and FDA Staff: Display Accessories for Full-Field Digital Mammography Systems-Premarket Notification (510(k)) Submissions
- . Visual check of presence or absence of miscellaneous artifacts on the display screen as specified in the TG18 guideline
- . The maximum number allowed for each type of pixel defects/faults agreed with the manufacturer from which Eizo buys the LCD panels for RadiForce MX270W
The test results showed that the RadiForce MX270W has display performances substantially equivalence to those of the predicate device, RadiForce RS210. Besides, the display performances of the RadiForce MX270W meet the pre-defined criteria when criteria are set.
No animal or clinical testing was performed on the RadiForce MX270W.
10.Conclusion
The 3.7MP color LCD monitor, RadiForce MX270W is substantially equivalent to the predicate device with respect to technical characteristics, performance, application and intended use. The specifications of the primary component employed by the proposed device are superior to those of the predicate device and other differences have been independently validated. Any differences between the devices do not affect safety or effectiveness.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized abstract symbol resembling an eagle or bird in flight, composed of three curved lines. The symbol is positioned to the right of the text, which reads "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular fashion around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-00002
Mr. Hiroaki Hashimoto Manager EIZO NANAO Corporation 153 Shimokashiwano HAKUSAN ISHIKAWA 924-8566 JAPAN
APR 2 0 2012
Re: K113240
Trade/Device Name: 3.7MP Color LCD Monitor, RadiForce MX270W Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 12, 2012 Received: April 17. 2012
Dear Mr. Hashimoto:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act that I Drimes and regulations administered by other Federal agencies. You must or uny I out all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indications for Use Form
510(k) Number (if known):
3.7MP Color LCD Monitor, RadiForce MX270W Device Name:
Indications for Use:
The RadiForce MX270W is intended to be used in displaying and viewing digital images for diagnosis of X-ray or MRI, etc. by trained medical practitioners. The device is not for use for screening or diagnostic mammography.
X Over-The-Counter Use Prescription Use Prescription Use
(Part 21 CFR 801 Subpart D) AND/OR (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary S. Pastel
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K113240
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